Essure is a form of birth control marketed by one of the largest pharmaceutical companies – Bayer. It is a minimally invasive form of sterilization for women. They insert a small device into the fallopian tube that prevents fertilization.
Essure hit the market in 2002 when it was deemed safe by the FDA. The whole point of Essure was to provide an alternative to tubal ligation. It was considered safer and less invasive, and can be implanted using an out-patient procedure rather than a full-blown surgery.
It takes about 3 months for the insert to start working, by creating scar tissue in the fallopian tubes. After the 3 months, patients visit their doctor for a follow-up visit. Once a doctor confirms that the implant has taken, patients can abandon all other sources of birth control.
What Kinds of Problems are Caused by Essure?
Like so many other dangerous drugs and devices, Essure seems to have caused more problems than it’s solved. To date, the following complications have resulted from the Essure implant:
- Pregnancy – Despite the promise of infertility, some women have gotten pregnant with the Essure implant.
- Perforations in the Fallopian tubes – The insert itself has caused perforations in the fallopian tubes. Women have needed to get surgery to repair these issues.
- Pain and bleeding – Some women have experienced heavy bleeding and pain after having the Essure implant procedure.
- Infection – Although most patients have been successfully treated for infections, there are some who’ve experienced serious complications from these infections.
- Shifting Coils – The coils from the Essure implant move to other parts of the abdominal cavity. This can be painful, dangerous and requires surgery to be corrected.
- Death – Although there have not been many deaths, some women have died after getting the Essure procedure.
These issues form the basis for much of the Essure litigation. Personal injury attorneys have filed hundreds of lawsuits against Bayer for issues caused by their birth control device.
What Are the Claims of Essure Plaintiffs?
There are always risks with new medical devices and medications. We know this. However, we’re usually offered a fair assessment of risks and benefits when considering a new medical device.
The plaintiffs in the Essure cases claim that they weren’t provided with warnings of the risks associated with Essure. Bayer and its marketers intentionally hid the risks of Essure. In fact, they still deny the fact that their product is dangerous at all.
Personal injury attorneys are asserting that Bayer didn’t just lie to the public. Their lawsuits allege that Bayer actually hid information from the FDA when their product was submitted for approval.
In a case decided last year in Philadelphia, a judge did agree that Bayer his known risks from the FDA and the public. They allowed a case filed by 5 plaintiffs to continue despite the defendant’s objections.
Many Cases Were Filed in California
There were over 1,000 Essure lawsuits filed in the State of California since 2016. A judge there rules that all of these cases would be centralized in Alameda County. The goal is that, if these cases are streamlined, the plaintiffs will be able to coordinate their efforts more easily.
Since the decision in 2016, a Superior Court judge decided that some of these cases could be removed to Los Angeles Superior Court. This is not good news for Bayer. They were hoping to remove the cases to Federal Court. This request was denied.
All of the Essure cases will be handled together before something called a Judicial Council Coordinated Proceedings.
Is Essure Still on the Market?
Shortly after the first wave of lawsuit filings, the FDA ordered Bayer to put very explicit warnings on their packaging. The company was required to add a black box label highlighting all of the risks of Essure. It must include the risks associated with the insertion and removal of the device.
There have been almost 10,000 complaints made to the FDA about the Essure implants. Bayer even set up toll-free numbers to receive and purportedly address any customer complaints or concerns.
There have been congressional hearings on the Essure issue. The FDA has also conducted very in-depth investigations into the product. After issuing many new requirements to Bayer, the device was eventually removed from the market.
Toward the end of 2018, Bayer did pull its Essure implant device from the market. They insist that this had nothing to do with the device’s safety. They simply said they did it because sales of Essure had gone down so much because of the negative publicity of the lawsuits.
If you or a loved one have suffered complications as a result of an Essure implant, contact a personal injury attorney today.